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Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171184
First received: September 12, 2005
Last updated: January 14, 2008
Last verified: January 2008
History of Changes
  Purpose

The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.


Condition Intervention Phase
Overactive Bladder
 Drug: Darifenacin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.

Secondary Outcome Measures:
  • Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.
  • Safety and tolerability.
  • Quality of life at week 6 and/or 12.

Enrollment: 400
Study Start Date: April 2005
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: 1
Darifenacin
 Drug: Darifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Other Name: Enablex
Placebo Comparator: 2
Placebo
 Drug: Placebo
Placebo tablet once daily with sham titration

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Symptoms of OAB for at least six months prior to Visit 3
  • Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
  • ≥ 1 UUIE on average per day and
  • ≥ 10 episodes of micturition on average per day

Exclusion Criteria:

  • A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization
  • Post-void residual (PVR) urinary volume > 100 ml
  • Clinically significant stress urinary incontinence as determined by the investigator
  • Clinically significant bladder outlet obstruction as determined by the investigator
  • Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Other protocol inclusion / exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171184

Locations
United States, Texas
Scott Department of Urology Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novartis
Procter and Gamble
Investigators
Study Chair: Novartis East Hanover NJ
  More Information

Additional Information:
Novartis patient recruitment website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00171184     History of Changes
Other Study ID Numbers: CDAR328A2409
Study First Received: September 12, 2005
Last Updated: January 14, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Darifenacin
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013